Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV

• ClinicalTrials.gov Identifier: NCT03440840
• Recruitment Status: Active, not recruiting
• First Posted: February 22, 2018
• Last Update Posted: July 2, 2021
• Sponsor: Nova Southeastern University
• Information provided by (Responsible Party): Raymond Ownby, M.D., Nova Southeastern University

Study Description

Brief Summary:

This study investigates the effectiveness of computer-based cognitive training with or without transcranial direct current stimulation (tDCS) in improving the functioning of older individuals with HIV-related cognitive dysfunction.

Condition or disease	Intervention/treatment	Phase
HIV-related Mild Neurocognitive Disorder	Procedure: Transcranial Direct Current Stimulation (tDCS); Behavioral: Computer-based Cognitive Training; Behavioral: Watching Educational Videos	Not Applicable

Detailed Description:

In spite of advances in its treatment, persons with HIV continue to develop HIV-associated neurocognitive disorders (HAND) over time. HAND may be an even more significant problem in older persons (age 50+) with HIV who may experience age-related changes in cognition in addition to HAND. Because of HAND's impact on patients' functioning and quality of life, treatments are needed. Pharmacologic treatments have, in general, been ineffective and investigators have argued that computer delivered cognitive training may be an effective alternative. While results of small studies have been encouraging, the effect size of cognitive training may be small and of unclear practical importance. The nature of cognitive training programs, often building on laboratory measures of cognition, may reduce how inherently interesting (i.e., fun) they are, limiting their uptake outside of paid research studies. Others have argued for the use of computer games targeting psychomotor speed, problem solving, and visuospatial skills to improve cognitive function in older adults. Data support the utility of this approach, but again effect sizes may be small.

Transcranial direct current stimulation (tDCS) may be an effective way to enhance the effects of cognitive training. It involves the application of a small electric current (1-2 mA) to the head, inducing small currents within the brain that enhance cognitive training. Multiple studies have shown that tDCS enhances cognition, including attention and psychomotor speed. The investigators previously completed a single-blind pilot study of individuals with HIV-related mild neurocognitive disorder using a high-interest car racing game with or without tDCS. Results were encouraging in showing moderate to large effect sizes consistent with tDCS enhancement of cognitive function after six 20-minute training sessions over two weeks. Participants' subjective reports of cognitive difficulties supported observed effects on objective measures, and their mood improved. The intervention was acceptable to participants, many of whom stated they enjoyed it. Everyone indicated a willingness to participate in a similar study in the future.

In this study the investigators will expand on a pilot-tested training intervention with 120 individuals randomly assigned to an attention control condition or game-based cognitive training with either sham or active tDCS. The investigators will employ a battery of cognitive measures as well as self-report measures of mood, cognitive difficulties, and everyday functioning in order to evaluate the effects of study interventions.

Participants will first be screened for eligibility by telephone, and then scheduled for a visit during which their eligibility will be further assessed. Those who are eligible based on inclusion and exclusion criteria will complete a battery of measures of their cognitive and functional status. They will then complete six training sessions over a period of three weeks, and then once again complete the battery of assessments. Participants will then be asked to return one month after the post-training assessment to evaluate the persistence of training effects.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized parallel group
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Individuals will receive either active or sham tDCS. The outcomes assessor will be blind to treatment group assignment.
• Primary Purpose: Treatment
• Official Title: Computer Training and Transcranial Direct Current Stimulation for Cognition in HIV
• Actual Study Start Date: January 16, 2018
• Actual Primary Completion Date: October 15, 2019
• Estimated Study Completion Date: November 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Computer Training with active tDCS; Participants randomized to this arm will receive computer-based cognitive training using a car racing game with active transcranial direct current stimulation (tDCS).	Procedure: Transcranial Direct Current Stimulation (tDCS); Application of a small electrical current (1-2 mA) across the head.; Other Name: tDCS; Behavioral: Computer-based Cognitive Training; Use of computer-delivered games or exercises with the goal of improving cognitive performance.; Other Name: Cognitive Training
Active Comparator: Computer Training with sham tDCS; Participants randomized to this arm will receive computer-based cognitive training using a car racing game with sham transcranial direct current stimulation (tDCS).	Behavioral: Computer-based Cognitive Training; Use of computer-delivered games or exercises with the goal of improving cognitive performance.; Other Name: Cognitive Training
Placebo Comparator: Computer Training with or without tDCS; Participants in this arm will watch educational videos as a comparator to computer training with the car racing game (watching educational videos).	Procedure: Transcranial Direct Current Stimulation (tDCS); Application of a small electrical current (1-2 mA) across the head.; Other Name: tDCS; Behavioral: Watching Educational Videos; Watching educational videos and answering questions about them

Outcome Measures

Primary Outcome Measures :

1. Psychomotor speed [ Time Frame: 3 weeks ]
   Ability of the participant to attend to and use complex stimuli while making a motor response

Secondary Outcome Measures :

1. Functional Status [ Time Frame: 3 weeks ]
   Participant performance on observed tasks of daily living
2. Participant Assessment of Own Functioning (PAOF) [ Time Frame: 3 weeks ]
   Participant self-report of issues related to cognitive and sensory functioning
3. Center for Epidemiological Studies Depression scale (CES-D) [ Time Frame: 3 weeks ]
   Participant self-report of mood

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Treated with antiretroviral medication for at least one month
• Meet criteria for Mild Neurocognitive Disorder

Exclusion Criteria:

• Seizure disorder
• Recent head injury or surgery
• Personal or family history of bipolar disorder;
• Some medications
• Left handedness
• HIV Dementia

Contacts and Locations

Locations

United States, Florida

NSU Psychiatry Research Office

Fort Lauderdale, Florida, United States, 33328

Sponsors and Collaborators

Nova Southeastern University

Investigators

• Principal Investigator: Raymond L Ownby, MD, PhD; Nova Southeastern University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ownby RL, Kim J. Computer-Delivered Cognitive Training and Transcranial Direct Current Stimulation in Patients With HIV-Associated Neurocognitive Disorder: A Randomized Trial. Front Aging Neurosci. 2021 Nov 15;13:766311. doi: 10.3389/fnagi.2021.766311. eCollection 2021.

• Responsible Party: Raymond Ownby, M.D., Professor and Chair, Nova Southeastern University
• ClinicalTrials.gov Identifier: NCT03440840
• Other Study ID Numbers: AG056256
• First Posted: February 22, 2018
• Last Update Posted: July 2, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: After the conclusion of the study, de-identified study data will be shared by the study principal investigator with interested individuals.
• Supporting Materials: Study Protocol
• Time Frame: After study conclusion.
• Access Criteria: Researchers who indicate an interest in using the data for legitimate purposes.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Neurocognitive Disorders; Cognitive Dysfunction; Mental Disorders; Cognition Disorders